Leaflet: information for the user

Lacosamida Olpha 50 mg film-coated tablets

Lacosamida Olpha 100 mg film-coated tablets

Lacosamida Olpha 150 mg film-coated tablets

Lacosamida Olpha 200 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Lacosamida Olpha and what it is used for

2.What you need to know before you start taking Lacosamida Olpha

3.How to take Lacosamida Olpha

4.Possible side effects

5Storage of Lacosamida Olpha

6.Contents of the pack and additional information

What is Lacosamida

This medication contains lacosamida, which belongs to a group of medications called

“antiepileptic medications”. These medications are used to treat epilepsy.

•You have been prescribed this medication to reduce the number of seizures you experience.

What is Lacosamida used for

•Lacosamida is used:

• alone and in combination with other antiepileptic medications in adults, adolescents, and children aged 2 years and older to treat a certain type of epilepsy called “partial onset seizures with or without secondary generalization”. In this type of epilepsy, seizures affect only one side of the brain. However, they may then spread to larger areas in both sides of the brain;
• in combination with other antiepileptic medications in adults, adolescents, and children aged 4 years and older to treat primary generalized tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).

Do not take Lacosamida

•if you are allergic to lacosamida or any of the other ingredients in this medication

(listed in section 6). If you are unsure if you are allergic, consult your doctor.

•if you have a heart rhythm problem called second- or third-degree AV block.

Do not take this medication if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor before starting to use this medication if:

•you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medications such as lacosamida have had thoughts of self-harm or suicide. If you ever have this type of thought, contact your doctor immediately.

•you have a heart problem that affects heart rhythm and your pulse is often especially slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).

•you have a serious heart disease such as heart failure or have had a heart attack.

•you often feel dizzy or fall. Lacosamida may cause dizziness, which could increase the risk of accidental injuries or falls. This means you should be careful until you are accustomed to the effects of this medication.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking this medication.

If you are taking this medication, consult your doctor if you experience a new type of seizure or worsening of existing seizures.

If you are taking this medication and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting), consult your doctor immediately (see section 4).

Children

Lacosamida is not recommended for children under 2 years old with epilepsy characterized by the onset of partial seizures or for children under 4 years old with generalized tonic-clonic seizures. This is because it is not yet known if it is effective and safe for children in this age group.

Other medications and lacosamida

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart. The reason is that lacosamida may also affect the heart.

•medications to treat heart problems.

•medications that may increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medications called carbamazepine, lamotrigine, or pregabalin.

•medications used to treat certain types of arrhythmia or heart failure.

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking this medication.

Also inform your doctor or pharmacist if you are taking any of the following medications. The reason is that they may also increase or decrease the effect of lacosamida in your body.

•antifungal medications such as fluconazole, itraconazole, or ketoconazole.

•medications for HIV such as ritonavir.

•antibacterial medications such as clarithromycin or rifampicin.

•a medicinal herb used to treat mild anxiety and depression called St. John's Wort.

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking lacosamida.

Lacosamida and alcohol

As a precaution, do not take this medication with alcohol.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraceptives with their doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Lacosamida is not recommended during pregnancy, as its effects on the fetus are unknown.

It is not recommended to breastfeed while taking this medication, as it passes into breast milk. Immediately ask your doctor for advice if you are pregnant or plan to become pregnant. They will help you decide if you should take lacosamida or not.

Do not stop treatment without first speaking with your doctor, as this could increase seizures (crises). A worsening of your condition may also harm the fetus.

Driving and operating machinery

You should not drive, ride a bike, or use any tools or machines until you know if this medication affects you. The reason is that lacosamida may cause dizziness or blurred vision.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Other forms of this medication may be more suitable for children; consult your doctor or pharmacist.

Lacosamide Dosage

•Take lacosamide twice a day, with an interval of approximately 12 hours.

•Try to take it more or less at the same time each day.

•Take the lacosamide tablet with a glass of water.

•You can take lacosamide with meals or separately.

Normally, you will start taking a low dose each day and your doctor will gradually increase the dose over several weeks. When you reach the dose that works well for you, called the "maintenance dose," you will take the same amount each day. Lacosamide is used as long-term treatment. You should continue taking lacosamide until your doctor tells you to stop.

How much to take

The following are the normal recommended doses of lacosamide for different age groups and weights. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adults, adolescents, and children weighing 50 kg or more

When taking lacosamide alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of lacosamide twice a day. Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When taking lacosamide with other antiepileptic medications::

The usual starting dose is 50 mg twice a day.

Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 200 mg twice a day.

If you weigh 50 kg or more, your doctor may start the lacosamide treatment with a single "loading dose" of 200 mg. Then you will start taking the continuous maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

- In the treatment of partial seizures:note that this medication is not recommended for children under 2 years old.

- In the treatment of primary generalized tonic-clonic seizures:note that this medication is not recommended for children under 4 years old.

The dose depends on body weight. Normally, treatment starts with the syrup and only changes to tablets if the patient is able to take them and obtain the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more lacosamide than you should

If you have taken more lacosamide than you should, consult your doctor immediately. Do not attempt to drive.

You may experience:

•dizziness;

•sensation of dizziness (nausea) or dizziness (vomiting);

•seizures (crises), heart problems such as slow, fast, or irregular heartbeat, coma, or low blood pressure with tachycardia and sweating.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take lacosamide

•If you have forgotten to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.

•If you have forgotten to take a dose after 6 hours of the scheduled dose, do not take the missed dose, instead, take lacosamide at the next time you normally take it.

•Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with lacosamide

•Do not stop taking lacosamide without telling your doctor, as epilepsy may recur or worsen.

•If your doctor decides to stop your treatment with lacosamide, they will give you instructions on how to gradually reduce the dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, lacosamide may cause side effects, although not everyone will experience them.

The side effects in the nervous system, such as dizziness, may be more pronounced after a single "loading" dose.

Inform your doctor or pharmacist if you experience any of the following side effects:

Very common: may affect more than 1 in 10 patients

•Headache;

•Feeling dizzy or nauseous;

•Diplopia (double vision).

Common: may affect up to 1 in 10 patients

•Brief muscle spasms or muscle group spasms (myoclonic crises);

•Difficulty coordinating movements or walking;

•Problems maintaining balance, agitation (tremor), paresthesia (tingling), or muscle spasms, easy to fall and bruise;

•Memory problems, thinking problems, or difficulty finding words, confusion;

•Rapid, uncontrolled eye movements (nystagmus), blurred vision;

•Sensation of dizziness (vertigo), feeling drunk;

•Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;

•Decreased sensitivity, difficulty articulating words, attention alteration;

•Ringing in the ears like buzzing, beeping, or whistling;

•Irritability, difficulty sleeping, depression;

•Drowsiness, fatigue, or weakness (asthenia);

•Itching, rash.

Uncommon: may affect up to 1 in 100 patients

•Decreased heart rate, palpitations, irregular pulse, or other changes in heart electrical activity (conduction disorder);

•Exaggerated feeling of well-being, seeing and/or hearing things that are not real;

•Allergic reaction to taking the medication, hives;

•Blood tests may show abnormalities in liver function tests, liver damage;

•Thoughts of self-harm or suicide or attempted suicide: inform your doctor immediately;

•Feeling angry or agitated;

•Abnormal thoughts or loss of sense of reality;

•Severe allergic reactions, which cause swelling of the face, throat, hands, feet, ankles, or lower legs;

•Loss of consciousness;

•Abnormal involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from available data

•Abnormally fast ventricular heart rate (ventricular tachyarrhythmia);

•Sore throat, elevated temperature, and increased frequency of infections;

•Blood tests may show severe decrease in a specific type of white blood cell (agranulocytosis);

•Severe skin reaction, which may include elevated temperature and other pseudogripal symptoms, facial rash, generalized rash with lymph node inflammation (enlarged lymph nodes);

•Blood tests may show increased levels of liver enzymes and increased levels of a type of white blood cell (eosinophilia);

•Generalized blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis):

•Seizures.

Other side effects in children

Additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), behavioral changes, not acting normally (abnormal behavior), and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lacosamida Olpha

• The active ingredient is lacosamida.

Each Lacosamida Olpha 50 mg tablet contains 50 mg of lacosamida.

Each Lacosamida Olpha 100 mg tablet contains 100 mg of lacosamida.

Each Lacosamida Olpha 150 mg tablet contains 150 mg of lacosamida.

Each Lacosamida Olpha 200 mg tablet contains 200 mg of lacosamida.

• The other components are:

Core of the tablet : microcrystalline cellulose (101), microcrystalline cellulose (102), crospovidone type A, colloidal silicon dioxide, hydroxypropylmethylcellulose (partially substituted), hydroxypropylmethylcellulose, magnesium stearate.

Covering

50 mg :

hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (E322), iron oxide red (E172), iron oxide black (E172)

100 mg :

hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (E322), iron oxide yellow (E172)

150 mg :

hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521), lecithin (E322), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)

200 mg

hypromellose 6mPas (E464), hypromellose 15mPas (E464), titanium dioxide (E171)

talc (E553b), polyvinyl alcohol (E1203), polyethylene glycol 3350 (E1521)

lecithin (E322), indigo carmine lake (E132)

Appearance of the product and contents of the package

• Lacosamida Olpha 50 mg are oval-shaped, biconvex, pink-colored tablets, marked with “L50” on one face and smooth on the other.

• Lacosamida Olpha 100 mg are oval-shaped, biconvex, yellow-colored tablets, marked with “L100” on one face and smooth on the other.

• Lacosamida Olpha 150 mg are oval-shaped, biconvex, salmon-colored tablets, marked with “L150” on one face and smooth on the other.

• Lacosamida Olpha 200 mg are oval-shaped, biconvex, blue-colored tablets, marked with “L200” on one face and smooth on the other.

Lacosamida Olpha is available in blister packs of 14, 28, 56, 98, and 168 tablets, with aluminum blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

Responsible manufacturer

Macleods Pharma UK Limited.

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB,

United Kingdom

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, 62-020

Swarzedz, Poland

Last review date of this prospectus:

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )